Dive Brief:

The biotech intends to file for approval of the inhalable levodopa with the Food and Drug Administration sometime in the second quarter.

Acorda is also conducting two long-term studies to assess the safety profile of CVT-30. Twelve-month data is expected later in the first quarter.

Dive Insight:

Acorda is moving swiftly to file for approval of its levodopa reformulation. The company announced positive results from the SPAN-PD trial on Feb. 9 which showed improvement in the Unified Parkinson’s Disease Rating Scale-Part 3 (UPDRS III) score relative to placebo at 30 minutes post-treatment.

While oral levodopa is a common treatment for the disease, Acorda believes that the inhalable version can offer patients a more rapid onset of treatment and more reliable delivery.

The treatment is meant for patients who have "off" episodes, or periods when Parkinson’s symptoms flare up.

The company will report the full results at an upcoming medical meeting and expects to file for approval in Europe before the end of the year.

The SPAN-PD study was meant to assess two dosage levels of CVT-301 — 60mg and 84mg — vs placebo. There were six serious adverse events in the 60mg arm, two in the 84mg and three in the placebo arm. Three patients taking the drug discontinued the drug due to cough and one patient on the 60mg dose committed suicide, but it was deemed unrelated to the drug.